unit 4 Flashcards
What is pharmaceutical formulation
- Formation of pharmaceutical product
- Formulation development outlines the key aspects of API excipients,
- Associated interactions
- Manufacturing Procedures
What does the quality of medicinal products involve
- facility and equipment
- validation
- training
- documentation
- auditing
- testing
- specifications
How can pharmaceutical industry mplement sustainable practices in order to minimize its environmental footprint.
-reduce greenhouse gas emissions
-conserve natural resources
- address the increasing concerns about climate change.
What is a dosage form
- physical form of a drug such as a solid, liquid or gas.
- Common dosage forms include tablets, capsules, semisolids, solutions, injections and aerosols.
What are types of solid dosage forms
- tablet, capsules, chewing gum , pellets, films
Merits of solid dosage forms
dose accuracy, stability of the drug, easy to pack and handle, portability, reproducibility.
Demerits of solid dosage forms
- Not suitable for unconcsious patients.
- Formulation complications
What are types of liquid dosage forms - monophasic.
solutions, elixir, syrups
Merits of liquid dosage forms - monophasic.
easy to swallow and manufacture
fast absorption
Demerits of liquid dosage forms - monophasic.
non uniformity of dosage
prone to microbial attack
Liquid dosage forms biphasic.
suspensions
emulsions
Merits of Liquid dosage forms biphasic
less processing steps
less excipients required comapred to tablets.
Demerits of Liquid dosage forms biphasic.
less stability
unsuitable, unpleaseant taste and obnoxious drugs
Semisolid dosage forms
creams, gels, liniment, lotion, ointment
Merits of semiisolid dosage forms
-easy to use
-more stable than liquid dosage form
-local action of drug on affected area
- patient convenience easy to apply& remove
Demerits of semisolid dosage forms
- difficult to handle
- chance of contamination
- may cause staining, irration
- more prone to environment effect
Merits of Gaseous dosage forms
- easy to handle, convenient
- withdrawal of dose without contamination
- provides medication to local area
- tamper proof
Demerits of gaseous dosage forms
- expensive
- limited safety
- may cause environmental hazards
What is the overall aim of dosage form design
increase the stability of the drug substances to extend its shelf life, ensure accurate dosing and deliver the drug in suitable form.
Chemical properties of dosage form
structure, form, and reactivity
Physical properties of dosage form
physical description,
particle size,
particle shape,
flowability,
powder density,
crystalline structure,
melting point,
solubility
Chemical analysis in preformulation
identification of drug molecule - UV -Vis. IR, DSC
Assay - HPLC, TLC
Physiochemical properties
solubility, pH, log P, pKa, dissolution
method/analysis of Physiochemical properties
salt forms, co-solvent, complexation, pro - drug.
Pharmaceuitical analysis
Solid state stability - temp, humidity, light
Chemical compatibility - processing
Biopharmaceutical properties - ADME
Physical analysis
Hygroscopicity - Karl fisher, Gas chromotography, TGA
Melting point - DSC- polymorphism, hydrate & solvent.
Microscopy - particle shape and size
Dosage forms development
dosage forms development is a complex process that involves the integration of multiple disciplines. The goal of this process is to create a safe and effective drug product that meets the needs of the patient.
process
- involves combining different inactive substances with the active pharmaceutical ingredient (API) to produce an end- product for patients.
- Pharmaceutical excipients are classified according to function they performed.
- Once the formulation and dosage form have been developed
- conduct preclinical and clinical studies to evaluate the safety and efficacy of the drug product.
- This includes conducting animal studies to evaluate the pharmacokinetics and pharmacodynamics of the drug product, as well as conducting human studies to evaluate the safety and efficacy of the drug product in humans.
- the drug product must be manufactured in accordance with good manufacturing practices
- ensuring that the drug product is manufactured in a clean and sterile environment, and that the drug product meets all regulatory requirements.
